gentamicin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
aminoglycosides, antibiotics obtained from various Micromonospora 4265 1405-41-0

Description:

MoleculeDescription

Synonyms:

  • gentamicin sulfate
  • gentamicin
  • alcomicin
  • gentacin
  • gentamicine sulfate
A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS.
  • Molecular weight: 1390.73
  • Formula: C60H123N15O21
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
0.24 g P

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.28 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.33 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
June 19, 1970 FDA SCHERING

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 623.66 14.65 576 19644 262839 63205963
Premature delivery 404.82 14.65 196 20024 30085 63438717
Normal labour 396.69 14.65 77 20143 440 63468362
Delivery 335.61 14.65 80 20140 1323 63467479
Drug reaction with eosinophilia and systemic symptoms 248.36 14.65 147 20073 33689 63435113
Renal tubular necrosis 199.21 14.65 90 20130 11788 63457014
Multiple organ dysfunction syndrome 190.19 14.65 152 20068 56600 63412202
Toxic epidermal necrolysis 157.48 14.65 99 20121 25235 63443567
Pathogen resistance 131.67 14.65 56 20164 6342 63462460
Septic shock 118.16 14.65 125 20095 66504 63402298
Maternal exposure during pregnancy 115.24 14.65 231 19989 219831 63248971
Peritonitis bacterial 114.85 14.65 47 20173 4832 63463970
Renal failure 111.57 14.65 161 20059 117491 63351311
Sepsis 104.26 14.65 180 20040 152943 63315859
Ototoxicity 89.14 14.65 28 20192 1334 63467468
Bartter's syndrome 83.19 14.65 13 20207 12 63468790
Peritonitis 82.20 14.65 57 20163 17097 63451705
Anaphylactic reaction 80.17 14.65 102 20118 65998 63402804
Abdominal discomfort 79.41 14.65 6 20214 320879 63147923
Eosinophilia 78.41 14.65 62 20158 22694 63446108
Product use in unapproved indication 77.46 14.65 174 20046 178906 63289896
Toxic skin eruption 76.67 14.65 49 20171 12836 63455966
Mucosal inflammation 72.65 14.65 82 20138 46846 63421956
Drug intolerance 70.44 14.65 8 20212 308653 63160149
Drug resistance 69.55 14.65 58 20162 22875 63445927
Nephropathy toxic 69.01 14.65 41 20179 9438 63459364
Antibiotic level above therapeutic 67.46 14.65 17 20203 357 63468445
Pyrexia 67.33 14.65 312 19908 470166 62998636
Joint swelling 66.61 14.65 12 20208 327654 63141148
Excessive eye blinking 62.20 14.65 21 20199 1259 63467543
Shock haemorrhagic 59.79 14.65 38 20182 9857 63458945
Rheumatoid arthritis 56.85 14.65 7 20213 253812 63214990
Systemic lupus erythematosus 54.34 14.65 3 20217 208915 63259887
Neutropenic sepsis 52.82 14.65 43 20177 16395 63452407
Premature baby 51.88 14.65 47 20173 20688 63448114
Stevens-Johnson syndrome 51.81 14.65 51 20169 24899 63443903
Nasopharyngitis 50.19 14.65 10 20210 254247 63214555
Tubulointerstitial nephritis 49.58 14.65 45 20175 19858 63448944
Oliguria 47.77 14.65 32 20188 9069 63459733
Endocarditis 47.50 14.65 27 20193 5723 63463079
Arthropathy 46.83 14.65 9 20211 234783 63234019
Headache 46.24 14.65 82 20138 633159 62835643
Fall 45.61 14.65 35 20185 392299 63076503
Vestibular disorder 44.99 14.65 17 20203 1414 63467388
Metabolic alkalosis 44.45 14.65 21 20199 3040 63465762
Oropharyngeal oedema 44.30 14.65 12 20208 337 63468465
Candida infection 42.95 14.65 49 20171 28302 63440500
Drug interaction 42.80 14.65 165 20055 228966 63239836
Intraventricular haemorrhage neonatal 41.62 14.65 10 20210 171 63468631
Linear IgA disease 41.18 14.65 16 20204 1435 63467367
Fatigue 40.09 14.65 147 20073 887881 62580921
Arthritis bacterial 39.50 14.65 25 20195 6438 63462364
Umbilical erythema 38.02 14.65 8 20212 72 63468730
Renal injury 37.51 14.65 28 20192 9411 63459391
Therapeutic product effect decreased 37.28 14.65 8 20212 193179 63275623
Pancytopenia 37.26 14.65 90 20130 96843 63371959
Foetal exposure during pregnancy 36.66 14.65 48 20172 31914 63436888
Abscess neck 36.52 14.65 12 20208 661 63468141
Anuria 36.52 14.65 31 20189 12520 63456282
Pain 36.49 14.65 118 20102 740510 62728292
Contraindicated product administered 36.35 14.65 12 20208 217636 63251166
Renal impairment 36.08 14.65 84 20136 88271 63380531
Mental status changes postoperative 35.62 14.65 9 20211 191 63468611
Enterococcal infection 35.08 14.65 25 20195 7823 63460979
Musculoskeletal stiffness 34.90 14.65 8 20212 184610 63284192
Hyperchlorhydria 34.20 14.65 15 20205 1829 63466973
Disseminated intravascular coagulation 34.19 14.65 36 20184 19015 63449787
Confusion postoperative 33.78 14.65 9 20211 237 63468565
Haemodynamic instability 33.73 14.65 26 20194 9164 63459638
Liver abscess 33.70 14.65 17 20203 2837 63465965
Noninfectious peritonitis 33.45 14.65 8 20212 134 63468668
Weight increased 33.28 14.65 21 20199 260771 63208031
Sepsis syndrome 32.57 14.65 12 20208 930 63467872
Escherichia infection 32.08 14.65 29 20191 12725 63456077
Cholestasis 31.90 14.65 43 20177 29391 63439411
Neutropenia 31.82 14.65 125 20095 174880 63293922
Tendon necrosis 31.80 14.65 5 20215 5 63468797
Renal tubular disorder 31.74 14.65 16 20204 2666 63466136
Skin test positive 31.63 14.65 11 20209 721 63468081
Acute respiratory distress syndrome 31.21 14.65 38 20182 23496 63445306
Product dose omission issue 31.11 14.65 18 20202 234295 63234507
Thrombocytopenia 30.81 14.65 112 20108 151045 63317757
Peripheral swelling 30.52 14.65 24 20196 265918 63202884
Deafness neurosensory 30.22 14.65 19 20201 4836 63463966
Folate deficiency 29.98 14.65 15 20205 2460 63466342
Crystalluria 28.95 14.65 9 20211 414 63468388
Discomfort 28.35 14.65 9 20211 167365 63301437
Arthralgia 27.85 14.65 91 20129 569619 62899183
Retinal infarction 27.59 14.65 6 20214 64 63468738
Blood creatinine increased 26.99 14.65 75 20145 87769 63381033
Procedural hypertension 26.91 14.65 8 20212 316 63468486
Therapeutic product effect incomplete 26.67 14.65 4 20216 125052 63343750
Rash erythematous 26.32 14.65 48 20172 42462 63426340
Guillain-Barre syndrome 26.17 14.65 16 20204 3877 63464925
Application site scab 26.10 14.65 7 20213 189 63468613
Necrotising enterocolitis neonatal 25.46 14.65 7 20213 208 63468594
Endocarditis bacterial 25.27 14.65 9 20211 633 63468169
Rash maculo-papular 25.00 14.65 40 20180 31856 63436946
Lemierre syndrome 24.90 14.65 6 20214 104 63468698
Morganella infection 24.88 14.65 9 20211 662 63468140
Lactic acidosis 24.68 14.65 44 20176 38243 63430559
Puerperal pyrexia 24.63 14.65 5 20215 37 63468765
Hypoglossal nerve paresis 24.43 14.65 6 20214 113 63468689
Blood phosphorus decreased 24.20 14.65 16 20204 4437 63464365
Toxic shock syndrome streptococcal 24.04 14.65 6 20214 121 63468681
Infusion related reaction 23.63 14.65 26 20194 245495 63223307
Device related infection 23.58 14.65 33 20187 23359 63445443
Neonatal respiratory failure 23.32 14.65 7 20213 286 63468516
Ejection fraction decreased 23.25 14.65 32 20188 22300 63446502
Vascular device infection 23.22 14.65 19 20201 7293 63461509
Peritoneal dialysis complication 22.87 14.65 10 20210 1210 63467592
Pericarditis 22.41 14.65 7 20213 131572 63337230
Pain in extremity 22.29 14.65 45 20175 331441 63137361
Injection site pain 21.94 14.65 7 20213 129793 63339009
Anaphylactic shock 21.86 14.65 32 20188 23601 63445201
Death neonatal 21.61 14.65 9 20211 966 63467836
Aspergillus infection 21.54 14.65 19 20201 8074 63460728
Purpura 21.30 14.65 22 20198 11363 63457439
Wound 21.01 14.65 13 20207 163250 63305552
Macroglossia 20.81 14.65 8 20212 697 63468105
Swelling 20.62 14.65 35 20185 275343 63193459
Hypopyon 20.52 14.65 8 20212 724 63468078
Brain abscess 20.39 14.65 11 20209 2107 63466695
Agranulocytosis 20.36 14.65 32 20188 25102 63443700
Inflammatory marker increased 20.12 14.65 17 20203 6822 63461980
Sepsis neonatal 19.98 14.65 7 20213 469 63468333
Hepatic enzyme increased 19.94 14.65 21 20199 202307 63266495
Kussmaul respiration 19.92 14.65 6 20214 248 63468554
Malaise 19.91 14.65 67 20153 415887 63052915
Drug level increased 19.90 14.65 30 20190 22706 63446096
Endophthalmitis 19.74 14.65 13 20207 3579 63465223
Immune reconstitution inflammatory syndrome 19.72 14.65 16 20204 6068 63462734
Nausea 19.66 14.65 176 20044 854295 62614507
Clostridial infection 19.65 14.65 14 20206 4378 63464424
Tachycardia 19.55 14.65 82 20138 118074 63350728
Psoriatic arthropathy 19.34 14.65 3 20217 91517 63377285
Gastrointestinal haemorrhage 19.00 14.65 63 20157 81113 63387689
Necrosis 19 14.65 15 20205 5472 63463330
Septic embolus 18.95 14.65 8 20212 889 63467913
Tonsillitis bacterial 18.86 14.65 5 20215 129 63468673
Neurotoxicity 18.68 14.65 25 20195 16965 63451837
Spinal subdural haematoma 18.40 14.65 5 20215 142 63468660
Anal ulcer 18.39 14.65 7 20213 594 63468208
Coagulation time prolonged 18.20 14.65 9 20211 1439 63467363
Acute generalised exanthematous pustulosis 18.20 14.65 20 20200 11079 63457723
Rash morbilliform 18.19 14.65 12 20208 3313 63465489
Hypoperfusion 18.09 14.65 9 20211 1458 63467344
Foetal heart rate decreased 18.01 14.65 5 20215 154 63468648
Haemolytic anaemia 17.93 14.65 19 20201 10106 63458696
Shock 17.81 14.65 29 20191 23434 63445368
Low birth weight baby 17.52 14.65 16 20204 7113 63461689
Musculoskeletal pain 17.43 14.65 4 20216 92273 63376529
Exfoliative rash 17.36 14.65 11 20209 2836 63465966
Gingival swelling 17.32 14.65 13 20207 4405 63464397
Urogenital disorder 17.20 14.65 4 20216 59 63468743
Human herpesvirus 6 infection 16.98 14.65 11 20209 2946 63465856
Dermatitis exfoliative 16.95 14.65 14 20206 5445 63463357
Umbilical cord around neck 16.86 14.65 5 20215 196 63468606
Infusion site necrosis 16.78 14.65 4 20216 66 63468736
Staphylococcal infection 16.59 14.65 39 20181 41217 63427585
Insomnia 16.44 14.65 27 20193 215225 63253577
Bacterial sepsis 16.30 14.65 12 20208 3946 63464856
Pseudo-Bartter syndrome 16.30 14.65 4 20216 75 63468727
Feeling abnormal 16.26 14.65 14 20206 148378 63320424
Geotrichum infection 16.25 14.65 6 20214 468 63468334
Haemodialysis 16.22 14.65 17 20203 8930 63459872
Petechiae 16.13 14.65 21 20199 13876 63454926
Toxic shock syndrome 16.10 14.65 7 20213 835 63467967
Drug eruption 16.02 14.65 31 20189 28663 63440139
Adverse drug reaction 15.99 14.65 3 20217 79711 63389091
Neonatal cardiac failure 15.79 14.65 3 20217 15 63468787
Staphylococcal sepsis 15.74 14.65 16 20204 8112 63460690
Candida test positive 15.69 14.65 7 20213 889 63467913
Asthenia 15.61 14.65 66 20154 383538 63085264
Product used for unknown indication 15.57 14.65 6 20214 526 63468276
Pancreatitis haemorrhagic 15.56 14.65 6 20214 527 63468275
Arthritis 15.23 14.65 9 20211 115912 63352890
Sudden visual loss 15.19 14.65 3 20217 19 63468783
Skin oedema 15.13 14.65 7 20213 966 63467836
Neonatal disorder 15.04 14.65 6 20214 577 63468225
Hypocalcaemia 15.01 14.65 32 20188 31681 63437121
Odynophagia 14.98 14.65 15 20205 7471 63461331
Bronchopulmonary aspergillosis 14.93 14.65 16 20204 8619 63460183
Corneal deposits 14.92 14.65 5 20215 293 63468509
Neuromuscular blockade 14.92 14.65 5 20215 293 63468509
Gait disturbance 14.92 14.65 22 20198 183156 63285646
Meconium in amniotic fluid 14.90 14.65 5 20215 294 63468508
Hydrops foetalis 14.80 14.65 6 20214 602 63468200

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 477.56 15.06 741 20542 304247 34631401
Drug reaction with eosinophilia and systemic symptoms 209.33 15.06 168 21115 32844 34902804
Pathogen resistance 202.69 15.06 104 21179 9378 34926270
Renal tubular necrosis 158.94 15.06 106 21177 15574 34920074
Eosinophilia 130.25 15.06 116 21167 26106 34909542
Drug resistance 91.44 15.06 95 21188 25832 34909816
Endocarditis 88.45 15.06 53 21230 6458 34929190
Rash maculo-papular 87.58 15.06 97 21186 28354 34907294
Crystalluria 86.48 15.06 25 21258 456 34935192
Spinal muscular atrophy 82.09 15.06 23 21260 373 34935275
Delusion of grandeur 75.76 15.06 28 21255 1132 34934516
Pneumococcal sepsis 72.63 15.06 27 21256 1110 34934538
Ototoxicity 71.85 15.06 31 21252 1886 34933762
Tubulointerstitial nephritis 70.49 15.06 75 21208 20949 34914699
Nephropathy toxic 69.15 15.06 59 21224 12529 34923119
Multiple organ dysfunction syndrome 67.53 15.06 146 21137 76420 34859228
Pyrexia 64.78 15.06 384 20899 332629 34603019
Peritonitis bacterial 61.15 15.06 41 21242 6069 34929579
Anaphylactic reaction 59.19 15.06 85 21198 32216 34903432
Toxic skin eruption 57.76 15.06 51 21232 11334 34924314
Red blood cell hyperchromic morphology 57.12 15.06 10 21273 10 34935638
Septic shock 56.63 15.06 131 21152 71703 34863945
Rhinalgia 56.44 15.06 22 21261 1031 34934617
Increased bronchial secretion 56.35 15.06 26 21257 1855 34933793
Motor neurone disease 55.16 15.06 18 21265 499 34935149
Stoma closure 52.39 15.06 15 21268 264 34935384
Sputum increased 50.63 15.06 26 21257 2344 34933304
Renal failure 50.18 15.06 184 21099 130373 34805275
Ischaemic cerebral infarction 49.49 15.06 21 21262 1226 34934422
Klebsiella infection 48.93 15.06 41 21242 8490 34927158
Fall 48.50 15.06 32 21251 202853 34732795
Vestibular disorder 48.49 15.06 20 21263 1087 34934561
Fatigue 48.01 15.06 96 21187 370557 34565091
Renal impairment 47.67 15.06 146 21137 94367 34841281
Death 47.49 15.06 108 21175 397941 34537707
Aminoaciduria 47.41 15.06 14 21269 276 34935372
Product dose omission issue 47.31 15.06 8 21275 119703 34815945
Linear IgA disease 47.23 15.06 22 21261 1604 34934044
Asthenia 47.09 15.06 48 21235 245203 34690445
Respiratory tract infection bacterial 45.31 15.06 22 21261 1760 34933888
Lower respiratory tract infection bacterial 43.74 15.06 15 21268 486 34935162
Lymphadenectomy 43.42 15.06 14 21269 373 34935275
Affective disorder 43.01 15.06 29 21254 4331 34931317
Toxic epidermal necrolysis 42.67 15.06 59 21224 21587 34914061
Purpura 42.25 15.06 41 21242 10270 34925378
Cerebral ischaemia 41.78 15.06 33 21250 6289 34929359
Disease complication 41.70 15.06 24 21259 2712 34932936
Bronchial disorder 40.80 15.06 19 21264 1384 34934264
Lymphocyte count abnormal 40.44 15.06 18 21265 1180 34934468
Chest X-ray abnormal 40.42 15.06 28 21255 4370 34931278
Cardiac valve vegetation 40.16 15.06 14 21269 477 34935171
Antimicrobial susceptibility test resistant 39.81 15.06 13 21270 361 34935287
Neonatal disorder 39.79 15.06 16 21267 814 34934834
Dizziness 39.45 15.06 45 21238 218476 34717172
Metabolic disorder 38.73 15.06 27 21256 4256 34931392
Auditory neuropathy spectrum disorder 38.43 15.06 6 21277 0 34935648
Deafness neurosensory 38.03 15.06 23 21260 2848 34932800
Fungal peritonitis 37.22 15.06 15 21268 768 34934880
Resuscitation 37.13 15.06 18 21265 1435 34934213
Cholestasis 36.88 15.06 62 21221 26886 34908762
Antibiotic level above therapeutic 36.20 15.06 11 21272 240 34935408
Acute generalised exanthematous pustulosis 35.66 15.06 31 21252 6745 34928903
Brain injury 34.16 15.06 29 21254 6113 34929535
Lung consolidation 32.96 15.06 28 21255 5908 34929740
Symmetrical drug-related intertriginous and flexural exanthema 32.39 15.06 11 21272 346 34935302
Headache 32.36 15.06 45 21238 200590 34735058
Aspergillus infection 31.34 15.06 38 21245 12216 34923432
Peritonitis 31.34 15.06 44 21239 16321 34919327
Scoliosis 31.01 15.06 20 21263 2773 34932875
Acinetobacter infection 30.98 15.06 15 21268 1192 34934456
Drug ineffective 30.91 15.06 418 20865 456333 34479315
Sepsis 30.26 15.06 189 21094 166372 34769276
Agranulocytosis 30.22 15.06 53 21230 23768 34911880
Haemodynamic instability 30.20 15.06 33 21250 9490 34926158
Metabolic acidosis 29.41 15.06 75 21208 43605 34892043
Necrotising colitis 29.38 15.06 14 21269 1074 34934574
Leukopenia 28.82 15.06 94 21189 62762 34872886
Demyelination 28.41 15.06 20 21263 3201 34932447
Intestinal ischaemia 28.25 15.06 29 21254 7765 34927883
Clostridium difficile colitis 28.22 15.06 41 21242 15689 34919959
Insomnia 28.20 15.06 14 21269 103893 34831755
Pulmonary haemorrhage 28.08 15.06 33 21250 10271 34925377
Premature baby 27.97 15.06 46 21237 19587 34916061
Hypoprothrombinaemia 27.85 15.06 10 21273 372 34935276
Bradycardia neonatal 27.71 15.06 13 21270 963 34934685
Arthralgia 27.54 15.06 38 21245 170003 34765645
Motor dysfunction 27.20 15.06 27 21256 6947 34928701
Infective aneurysm 26.73 15.06 11 21272 594 34935054
Nutritional condition abnormal 26.36 15.06 10 21273 435 34935213
Anisocytosis 25.85 15.06 10 21273 459 34935189
Lymphocyte count decreased 25.73 15.06 48 21235 22574 34913074
Fungaemia 25.14 15.06 17 21266 2551 34933097
Mucormycosis 25.04 15.06 24 21259 5918 34929730
Oliguria 24.79 15.06 28 21255 8352 34927296
Infusion site induration 24.04 15.06 8 21275 236 34935412
Schizophrenia 24.02 15.06 28 21255 8638 34927010
Listeriosis 23.96 15.06 12 21271 1026 34934622
Pseudomembranous colitis 23.86 15.06 17 21266 2774 34932874
Petechiae 23.75 15.06 29 21254 9389 34926259
Neonatal hypoxia 23.58 15.06 9 21274 398 34935250
Endocarditis candida 23.08 15.06 6 21277 72 34935576
Sepsis neonatal 23.07 15.06 8 21275 268 34935380
Cough 22.89 15.06 35 21248 150105 34785543
Hepatocellular injury 22.65 15.06 45 21238 22166 34913482
Weight decreased 22.45 15.06 46 21237 176255 34759393
Injury 22.42 15.06 43 21240 20644 34915004
Nosocomial infection 22.40 15.06 12 21271 1179 34934469
Intraventricular haemorrhage neonatal 22.09 15.06 8 21275 305 34935343
ADAMTS13 activity decreased 21.91 15.06 6 21277 89 34935559
Weight increased 21.75 15.06 15 21268 93018 34842630
Nausea 21.73 15.06 120 21163 339788 34595860
Pain 21.60 15.06 59 21224 204616 34731032
Lymphocyte morphology abnormal 21.55 15.06 9 21274 505 34935143
Polycythaemia 21.51 15.06 14 21269 1971 34933677
Blood alkaline phosphatase increased 21.47 15.06 54 21229 31121 34904527
Nasal discomfort 21.45 15.06 13 21270 1615 34934033
SARS-CoV-2 test positive 21.37 15.06 22 21261 5911 34929737
Therapeutic product effect incomplete 20.81 15.06 3 21280 50538 34885110
Staphylococcal infection 20.76 15.06 55 21228 32705 34902943
Neutrophil count increased 20.27 15.06 37 21246 17109 34918539
Embolia cutis medicamentosa 20.26 15.06 7 21276 232 34935416
Red blood cell schistocytes present 20.09 15.06 7 21276 238 34935410
Arterial angioplasty 20.06 15.06 5 21278 50 34935598
Chondrocalcinosis 19.84 15.06 8 21275 410 34935238
Neonatal candida infection 19.84 15.06 4 21279 13 34935635
Depression 19.75 15.06 18 21265 97080 34838568
Haemodialysis 19.71 15.06 28 21255 10498 34925150
Nasopharyngitis 19.63 15.06 9 21274 69959 34865689
Malignant neoplasm progression 19.54 15.06 15 21268 88031 34847617
Scrotal pain 19.53 15.06 10 21273 896 34934752
Uveal prolapse 19.21 15.06 3 21280 0 34935648
Haemorrhage neonatal 19.21 15.06 3 21280 0 34935648
Aortic valve disease 19.14 15.06 11 21272 1240 34934408
Myeloma cast nephropathy 19.09 15.06 5 21278 62 34935586
Hypersensitivity vasculitis 19.06 15.06 16 21267 3319 34932329
Rash erythematous 19.05 15.06 45 21238 24932 34910716
Muscle atrophy 19.00 15.06 23 21260 7381 34928267
Antineutrophil cytoplasmic antibody 19.00 15.06 4 21279 17 34935631
Thrombocytopenia 18.95 15.06 161 21122 156086 34779562
Abdominal pain upper 18.84 15.06 10 21273 71480 34864168
Bacillus infection 18.82 15.06 7 21276 288 34935360
Stenotrophomonas test positive 18.78 15.06 7 21276 290 34935358
Mast cell degranulation present 18.66 15.06 5 21278 68 34935580
Macrocytosis 18.66 15.06 10 21273 984 34934664
Herpes zoster reactivation 18.64 15.06 7 21276 296 34935352
Application site scab 18.53 15.06 5 21278 70 34935578
Foot amputation 18.16 15.06 9 21274 752 34934896
Cross sensitivity reaction 18.01 15.06 11 21272 1386 34934262
Cardiac valve abscess 17.99 15.06 4 21279 23 34935625
Blood creatinine increased 17.99 15.06 109 21174 94867 34840781
Secretion discharge 17.92 15.06 20 21263 5885 34929763
Disseminated mucormycosis 17.87 15.06 8 21275 532 34935116
Eosinophilic pneumonia acute 17.81 15.06 8 21275 536 34935112
Chronic obstructive pulmonary disease 17.77 15.06 4 21279 48914 34886734
Muscle spasms 17.65 15.06 12 21271 74989 34860659
Inappropriate schedule of product administration 17.50 15.06 8 21275 62288 34873360
Coronary artery disease 17.45 15.06 4 21279 48301 34887347
Cardiac arrest neonatal 17.32 15.06 4 21279 28 34935620
Jarisch-Herxheimer reaction 17.17 15.06 8 21275 583 34935065
Acute vestibular syndrome 17.14 15.06 3 21280 3 34935645
Hallucination, auditory 17.08 15.06 28 21255 11889 34923759
Peripheral swelling 17.03 15.06 13 21270 76528 34859120
Respiratory distress 16.93 15.06 54 21229 35611 34900037
Systemic mycosis 16.81 15.06 11 21272 1562 34934086
Stupor 16.80 15.06 14 21269 2877 34932771
CD4 lymphocytes increased 16.79 15.06 6 21277 220 34935428
Extrapyramidal disorder 16.78 15.06 29 21254 12851 34922797
Leukocyturia 16.46 15.06 8 21275 641 34935007
Neonatal respiratory distress syndrome 16.45 15.06 16 21267 4018 34931630
Aortic valve incompetence 16.24 15.06 19 21264 5885 34929763
Localised oedema 16.23 15.06 15 21268 3533 34932115
Dry gangrene 16.13 15.06 7 21276 432 34935216
Fixed eruption 16.04 15.06 11 21272 1689 34933959
Rash morbilliform 16.00 15.06 14 21269 3073 34932575
Respiratory alkalosis 15.98 15.06 11 21272 1698 34933950
Shock 15.73 15.06 41 21242 24138 34911510
Renal injury 15.63 15.06 26 21257 11169 34924479
Constipation 15.58 15.06 38 21245 136944 34798704
Hepatic cytolysis 15.54 15.06 30 21253 14466 34921182
Reticulocytosis 15.54 15.06 6 21277 274 34935374
Trichosporon infection 15.53 15.06 8 21275 726 34934922
Inflammation 15.45 15.06 45 21238 28250 34907398
Hyperhidrosis 15.43 15.06 14 21269 75678 34859970
Hypotension 15.36 15.06 204 21079 221445 34714203
Haemophagocytic lymphohistiocytosis 15.34 15.06 28 21255 12945 34922703
Pain in extremity 15.27 15.06 34 21249 126479 34809169
Staphylococcal bacteraemia 15.12 15.06 22 21261 8430 34927218

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Acute kidney injury 1076.89 12.97 1223 33671 518181 79191313
Drug reaction with eosinophilia and systemic symptoms 439.46 12.97 300 34594 63944 79645550
Renal tubular necrosis 318.47 12.97 174 34720 24865 79684629
Pathogen resistance 298.12 12.97 139 34755 14203 79695291
Eosinophilia 204.64 12.97 165 34729 45180 79664314
Multiple organ dysfunction syndrome 197.50 12.97 253 34641 119993 79589501
Toxic epidermal necrolysis 161.59 12.97 143 34751 44438 79665056
Ototoxicity 158.13 12.97 58 34836 3216 79706278
Septic shock 148.50 12.97 223 34671 122578 79586916
Peritonitis bacterial 139.94 12.97 73 34821 9494 79700000
Endocarditis 124.71 12.97 70 34824 10527 79698967
Renal failure 124.70 12.97 273 34621 200695 79508799
Nephropathy toxic 124.61 12.97 89 34805 20330 79689164
Antibiotic level above therapeutic 124.58 12.97 34 34860 706 79708788
Toxic skin eruption 124.30 12.97 92 34802 22201 79687293
Pyrexia 123.85 12.97 605 34289 678104 79031390
Anaphylactic reaction 121.67 12.97 166 34728 83577 79625917
Drug resistance 121.30 12.97 119 34775 42094 79667400
Crystalluria 116.14 12.97 34 34860 917 79708577
Rash maculo-papular 114.80 12.97 132 34762 55946 79653548
Tubulointerstitial nephritis 112.13 12.97 109 34785 38126 79671368
Vestibular disorder 102.18 12.97 39 34855 2416 79707078
Completed suicide 93.96 12.97 3 34891 245764 79463730
Sepsis 93.92 12.97 295 34599 269133 79440361
Linear IgA disease 86.33 12.97 37 34857 3095 79706399
Bartter's syndrome 85.63 12.97 14 34880 12 79709482
Spinal muscular atrophy 84.36 12.97 22 34872 381 79709113
Fall 84.17 12.97 55 34839 487574 79221920
Renal impairment 84.16 12.97 202 34692 157581 79551913
Drug intolerance 83.76 12.97 9 34885 264110 79445384
Peritonitis 80.47 12.97 79 34815 27957 79681537
Delusion of grandeur 79.03 12.97 28 34866 1404 79708090
Headache 74.31 12.97 107 34787 653665 79055829
Joint swelling 73.40 12.97 18 34876 288628 79420866
Fatigue 68.34 12.97 196 34698 929531 78779963
Product dose omission issue 67.89 12.97 13 34881 247524 79461970
Purpura 67.49 12.97 61 34833 19466 79690028
Pain 67.18 12.97 129 34765 703673 79005821
Rheumatoid arthritis 66.35 12.97 7 34887 208463 79501031
Nasopharyngitis 64.22 12.97 16 34878 253865 79455629
Pneumococcal sepsis 64.17 12.97 25 34869 1637 79707857
Weight increased 61.95 12.97 22 34872 277364 79432130
Cholestasis 60.61 12.97 93 34801 52016 79657478
Stevens-Johnson syndrome 58.92 12.97 79 34815 39087 79670407
Deafness neurosensory 58.76 12.97 37 34857 6861 79702633
Drug abuse 58.76 12.97 3 34891 162688 79546806
Motor neurone disease 58.13 12.97 18 34876 590 79708904
Haemodynamic instability 57.53 12.97 53 34841 17329 79692165
Stoma closure 55.77 12.97 15 34879 294 79709200
Abdominal discomfort 52.47 12.97 22 34872 250705 79458789
Acute generalised exanthematous pustulosis 52.10 12.97 50 34844 17204 79692290
Renal injury 51.01 12.97 49 34845 16878 79692616
Cardiac valve vegetation 50.83 12.97 18 34876 901 79708593
Clostridium difficile infection 49.38 12.97 76 34818 42609 79666885
Arthropathy 49.19 12.97 9 34885 177102 79532392
Arthralgia 48.46 12.97 112 34782 571691 79137803
Aminoaciduria 47.73 12.97 14 34880 380 79709114
Excessive eye blinking 46.57 12.97 20 34874 1681 79707813
Rhinalgia 46.27 12.97 22 34872 2345 79707149
Asthenia 45.99 12.97 97 34797 511592 79197902
Respiratory tract infection bacterial 45.86 12.97 21 34873 2056 79707438
Lymphocyte count abnormal 45.57 12.97 19 34875 1484 79708010
Agranulocytosis 45.00 12.97 75 34819 44955 79664539
Mucosal inflammation 44.90 12.97 101 34793 75479 79634015
Increased bronchial secretion 44.72 12.97 24 34870 3303 79706191
Noninfectious peritonitis 44.16 12.97 12 34882 245 79709249
Therapeutic product effect decreased 44.08 12.97 9 34885 163854 79545640
Blood creatinine increased 43.53 12.97 158 34736 154899 79554595
Klebsiella infection 42.71 12.97 43 34851 15677 79693817
Device related infection 42.42 12.97 63 34831 34231 79675263
Peripheral swelling 41.78 12.97 34 34860 269583 79439911
Oliguria 41.38 12.97 43 34851 16266 79693228
Metabolic alkalosis 40.57 12.97 25 34869 4464 79705030
Abdominal pain upper 40.27 12.97 24 34870 223795 79485699
Therapeutic product effect incomplete 39.76 12.97 7 34887 141638 79567856
Petechiae 39.71 12.97 47 34847 20518 79688976
Antimicrobial susceptibility test resistant 39.27 12.97 12 34882 376 79709118
Lung consolidation 39.16 12.97 32 34862 8915 79700579
Lower respiratory tract infection bacterial 39.12 12.97 15 34879 941 79708553
Aspergillus infection 39.02 12.97 45 34849 19116 79690378
Shock haemorrhagic 38.99 12.97 46 34848 20014 79689480
Ischaemic cerebral infarction 38.96 12.97 20 34874 2515 79706979
Renal tubular disorder 38.94 12.97 28 34866 6458 79703036
Infective aneurysm 38.34 12.97 15 34879 993 79708501
Oropharyngeal oedema 37.62 12.97 12 34882 434 79709060
Sputum increased 37.44 12.97 24 34870 4589 79704905
Fungal peritonitis 37.07 12.97 15 34879 1085 79708409
Bronchial disorder 36.42 12.97 19 34875 2470 79707024
Pain in extremity 36.29 12.97 65 34829 364473 79345021
Anaphylactic shock 36.03 12.97 60 34834 35936 79673558
Disease complication 35.96 12.97 24 34870 4913 79704581
Intentional product use issue 35.80 12.97 11 34883 152101 79557393
Affective disorder 34.83 12.97 29 34865 8290 79701204
Arthritis bacterial 34.39 12.97 30 34864 9136 79700358
Haemodialysis 34.22 12.97 41 34853 18127 79691367
Rash erythematous 34.08 12.97 77 34817 57692 79651802
Musculoskeletal stiffness 34.04 12.97 17 34877 174991 79534503
Enterococcal infection 33.96 12.97 38 34856 15622 79693872
Retinal infarction 32.52 12.97 9 34885 197 79709297
Endophthalmitis 32.44 12.97 25 34869 6403 79703091
Sepsis syndrome 32.43 12.97 15 34879 1502 79707992
Lymphadenectomy 31.85 12.97 14 34880 1245 79708249
Premature delivery 31.78 12.97 45 34849 23422 79686072
Glossodynia 31.54 12.97 4 34890 103333 79606161
Nausea 31.51 12.97 268 34626 956928 78752566
Vascular device infection 31.44 12.97 30 34864 10246 79699248
Aortic valve incompetence 31.42 12.97 29 34865 9501 79699993
Resuscitation 31.36 12.97 17 34877 2387 79707107
Cerebral ischaemia 31.10 12.97 31 34863 11164 79698330
Insomnia 30.96 12.97 37 34857 245133 79464361
Candida infection 30.88 12.97 58 34836 38156 79671338
Neutropenia 30.53 12.97 223 34671 287487 79422007
Brain injury 30.37 12.97 31 34863 11486 79698008
Dizziness 30.35 12.97 123 34771 526318 79183176
Tendon necrosis 30.21 12.97 5 34889 5 79709489
Chest X-ray abnormal 29.97 12.97 26 34868 7857 79701637
Contraindicated product administered 29.61 12.97 16 34878 157522 79551972
Myeloma cast nephropathy 29.55 12.97 8 34886 161 79709333
Endocarditis bacterial 29.25 12.97 14 34880 1515 79707979
Acinetobacter infection 29.07 12.97 17 34877 2760 79706734
Hypotension 28.88 12.97 307 34587 440010 79269484
Mental status changes postoperative 28.83 12.97 8 34886 177 79709317
Neutropenic sepsis 28.28 12.97 46 34848 27018 79682476
Blood alkaline phosphatase increased 28.17 12.97 76 34818 63588 79645906
Septic embolus 28.14 12.97 15 34879 2036 79707458
Anuria 28.09 12.97 40 34854 20923 79688571
Asthma 28.01 12.97 12 34882 135083 79574411
Infusion related reaction 27.76 12.97 36 34858 230201 79479293
Confusion postoperative 27.39 12.97 8 34886 214 79709280
Staphylococcal infection 27.22 12.97 71 34823 58224 79651270
Leukopenia 27.18 12.97 112 34782 116401 79593093
Face oedema 26.96 12.97 46 34848 28090 79681404
Rash morbilliform 26.92 12.97 22 34872 6128 79703366
Metabolic disorder 26.61 12.97 26 34868 9144 79700350
Tachycardia 26.36 12.97 150 34744 177618 79531876
Skin test positive 26.33 12.97 12 34882 1162 79708332
Sinusitis 26.32 12.97 28 34866 195473 79514021
Symmetrical drug-related intertriginous and flexural exanthema 26.19 12.97 11 34883 875 79708619
Abscess neck 26.11 12.97 12 34882 1185 79708309
Clostridium difficile colitis 26.09 12.97 49 34845 32234 79677260
Disseminated intravascular coagulation 26.03 12.97 52 34842 35790 79673704
Metabolic acidosis 25.65 12.97 87 34807 82442 79627052
Shock 25.64 12.97 58 34836 43490 79666004
Hepatic cytolysis 25.50 12.97 44 34850 27107 79682387
Hepatocellular injury 25.41 12.97 61 34833 47532 79661962
Hyperaldosteronism 25.41 12.97 9 34885 451 79709043
Haematochezia 25.33 12.97 4 34890 87641 79621853
Migraine 25.27 12.97 4 34890 87489 79622005
Hyperchlorhydria 25.18 12.97 14 34880 2065 79707429
Pseudomembranous colitis 25.17 12.97 20 34874 5354 79704140
Thrombocytopenia 25.00 12.97 200 34694 265059 79444435
Swelling 24.99 12.97 35 34859 216676 79492818
Loss of personal independence in daily activities 24.90 12.97 7 34887 102573 79606921
Corneal oedema 24.72 12.97 15 34879 2605 79706889
Hypoprothrombinaemia 24.60 12.97 10 34884 732 79708762
Blood pressure increased 24.51 12.97 34 34860 211326 79498168
Procedural hypertension 24.19 12.97 8 34886 325 79709169
Depression 24.03 12.97 36 34858 216754 79492740
Seizure 23.96 12.97 153 34741 188681 79520813
Blood cholesterol increased 23.79 12.97 4 34890 83716 79625778
Weight decreased 23.73 12.97 78 34816 355120 79354374
Peritoneal dialysis complication 23.57 12.97 14 34880 2340 79707154
Drug level increased 23.55 12.97 53 34841 39598 79669896
Muscle spasms 23.55 12.97 25 34869 174705 79534789
Hypopyon 23.51 12.97 11 34883 1131 79708363
Oscillopsia 23.49 12.97 7 34887 201 79709293
Fungaemia 23.48 12.97 18 34876 4573 79704921
Suicide attempt 23.48 12.97 4 34890 82928 79626566
Puerperal pyrexia 23.42 12.97 5 34889 34 79709460
Chest discomfort 23.18 12.97 16 34878 138028 79571466
Nasal discomfort 22.72 12.97 19 34875 5464 79704030
Endocarditis candida 22.69 12.97 6 34888 110 79709384
Intervertebral discitis 22.68 12.97 18 34876 4810 79704684
Motor dysfunction 22.58 12.97 30 34864 14703 79694791
Chronic obstructive pulmonary disease 22.33 12.97 5 34889 85414 79624080
Hypoglossal nerve paresis 22.24 12.97 6 34888 119 79709375
Lymphocyte morphology abnormal 22.14 12.97 10 34884 948 79708546
Psoriasis 21.96 12.97 6 34888 89581 79619913
Injection site pain 21.86 12.97 15 34879 129823 79579671
Discomfort 21.84 12.97 14 34880 125603 79583891
Inappropriate schedule of product administration 21.76 12.97 16 34878 133612 79575882
Arterial angioplasty 21.71 12.97 5 34889 50 79709444
Contusion 21.53 12.97 20 34874 148756 79560738
Hallucination, auditory 21.39 12.97 35 34859 20658 79688836
Dry mouth 21.37 12.97 6 34888 88013 79621481
Scoliosis 21.35 12.97 21 34873 7443 79702051
Folate deficiency 21.31 12.97 15 34879 3345 79706149
Drug interaction 21.22 12.97 276 34618 414907 79294587
Arthritis 21.10 12.97 12 34882 114868 79594626
Pyroglutamic acidosis 21.03 12.97 10 34884 1066 79708428
Blood culture positive 20.98 12.97 22 34872 8407 79701087
Suicidal ideation 20.93 12.97 4 34890 76336 79633158
Cough 20.92 12.97 86 34808 366703 79342791
Acute respiratory distress syndrome 20.91 12.97 54 34840 44013 79665481
Circulatory collapse 20.88 12.97 49 34845 37619 79671875
Escherichia infection 20.72 12.97 32 34862 17985 79691509
Lemierre syndrome 20.70 12.97 6 34888 156 79709338
Nutritional condition abnormal 20.68 12.97 10 34884 1107 79708387
Aortic valve disease 20.63 12.97 12 34882 1929 79707565
Helicobacter infection 20.55 12.97 3 34891 69701 79639793
Toxicity to various agents 20.38 12.97 105 34789 421435 79288059
Bacillus infection 20.36 12.97 10 34884 1145 79708349
Intestinal ischaemia 20.31 12.97 27 34867 13243 79696251
Mast cell degranulation present 20.30 12.97 5 34889 68 79709426
Cellulitis 20.28 12.97 98 34796 108962 79600532
Macroglossia 20.15 12.97 10 34884 1171 79708323
Wound 20.13 12.97 13 34881 116166 79593328
Wrong technique in product usage process 19.98 12.97 4 34890 73871 79635623
Learning disorder 19.87 12.97 8 34886 571 79708923
SARS-CoV-2 test positive 19.74 12.97 25 34869 11691 79697803
Constipation 19.71 12.97 61 34833 282989 79426505
ADAMTS13 activity decreased 19.70 12.97 6 34888 186 79709308
Psoriatic arthropathy 19.54 12.97 5 34889 77994 79631500
Gastrointestinal disorder 19.43 12.97 15 34879 122190 79587304
Neutrophil count increased 19.40 12.97 41 34853 29355 79680139
Osteoarthritis 19.34 12.97 7 34887 87302 79622192
Stenotrophomonas test positive 19.33 12.97 7 34887 374 79709120
Duodenal ulcer perforation 19.18 12.97 3 34891 66208 79643286
Pseudo-Bartter syndrome 19.15 12.97 5 34889 87 79709407
Feeling abnormal 19.07 12.97 25 34869 159174 79550320
Listeriosis 18.99 12.97 12 34882 2238 79707256
Pericarditis 18.98 12.97 11 34883 104225 79605269
Staphylococcal bacteraemia 18.91 12.97 25 34869 12193 79697301
Hypersensitivity vasculitis 18.87 12.97 19 34875 6924 79702570
Geotrichum infection 18.82 12.97 9 34885 972 79708522
Haemophagocytic lymphohistiocytosis 18.72 12.97 34 34860 21803 79687691
Memory impairment 18.69 12.97 13 34881 111721 79597773
Trichosporon infection 18.58 12.97 9 34885 999 79708495
Schizophrenia 18.57 12.97 28 34866 15412 79694082
Fluid retention 18.43 12.97 4 34890 69805 79639689
Demyelination 18.31 12.97 20 34874 8003 79701491
Drug ineffective 18.18 12.97 609 34285 1080304 78629190
Dyspnoea 18.17 12.97 265 34629 856760 78852734
Influenza 18.08 12.97 18 34876 129588 79579906
Malaise 17.97 12.97 133 34761 489736 79219758
Disseminated mucormycosis 17.90 12.97 8 34886 740 79708754
Antineutrophil cytoplasmic antibody 17.85 12.97 4 34890 35 79709459
Impaired healing 17.83 12.97 8 34886 87647 79621847
Rash macular 17.58 12.97 39 34855 28860 79680634
Skin lesion 17.56 12.97 49 34845 41795 79667699
Muscle atrophy 17.41 12.97 23 34871 11209 79698285
Reticulocytosis 17.36 12.97 7 34887 502 79708992
Exfoliative rash 17.30 12.97 14 34880 3845 79705649
CD4 lymphocytes increased 17.10 12.97 6 34888 292 79709202
Mycobacterium abscessus infection 16.95 12.97 9 34885 1213 79708281
Pulmonary valve disease 16.91 12.97 6 34888 302 79709192
Psychotic disorder 16.90 12.97 48 34846 41354 79668140
Toxic shock syndrome 16.76 12.97 9 34885 1240 79708254
Pancytopenia 16.72 12.97 127 34767 165618 79543876
Hepatitis 16.66 12.97 58 34836 55669 79653825
Type IV hypersensitivity reaction 16.62 12.97 14 34880 4067 79705427
Uveal prolapse 16.60 12.97 3 34891 7 79709487
Extrapyramidal disorder 16.58 12.97 33 34861 22646 79686848
Dermatitis exfoliative 16.52 12.97 22 34872 10807 79698687
HIV associated nephropathy 16.38 12.97 6 34888 331 79709163
Red blood cell schistocytes present 16.37 12.97 7 34887 582 79708912
Serratia infection 16.33 12.97 10 34884 1766 79707728
Bronchitis 16.18 12.97 20 34874 130624 79578870
Fungal endocarditis 16.09 12.97 7 34887 607 79708887
Tonsillitis bacterial 16 12.97 5 34889 169 79709325
Respiratory alkalosis 15.95 12.97 14 34880 4297 79705197
Foot amputation 15.93 12.97 8 34886 960 79708534
Musculoskeletal pain 15.72 12.97 13 34881 102341 79607153
Nasal congestion 15.55 12.97 7 34887 76545 79632949
Blood pressure fluctuation 15.54 12.97 5 34889 67140 79642354
Cardiac failure congestive 15.43 12.97 24 34870 142378 79567116
Liver abscess 15.43 12.97 16 34878 6038 79703456
Urogenital disorder 15.35 12.97 4 34890 69 79709425
Staphylococcal sepsis 15.34 12.97 25 34869 14701 79694793
Infusion site necrosis 15.30 12.97 4 34890 70 79709424
Chondrocalcinosis 15.28 12.97 8 34886 1048 79708446
Hepatic enzyme increased 15.23 12.97 36 34858 182574 79526920
Myalgia 15.16 12.97 37 34857 185604 79523890
Immune reconstitution inflammatory syndrome 15.11 12.97 24 34870 13817 79695677
Kussmaul respiration 15.00 12.97 6 34888 421 79709073
Eosinophilic pneumonia acute 14.98 12.97 8 34886 1090 79708404
Gait disturbance 14.95 12.97 44 34850 207462 79502032
Hypoperfusion 14.95 12.97 11 34883 2628 79706866
Endotracheal intubation 14.92 12.97 14 34880 4683 79704811
Dialysis 14.89 12.97 28 34866 18434 79691060
Systemic mycosis 14.85 12.97 11 34883 2655 79706839
Morganella infection 14.79 12.97 8 34886 1119 79708375
Infusion site induration 14.73 12.97 8 34886 1127 79708367
Antibiotic level below therapeutic 14.66 12.97 4 34890 83 79709411
Deafness 14.65 12.97 30 34864 21007 79688487
Mechanical ventilation 14.50 12.97 11 34883 2753 79706741
Spinal subdural haematoma 14.44 12.97 5 34889 234 79709260
Clostridial infection 14.38 12.97 15 34879 5699 79703795
Haematuria 14.37 12.97 64 34830 68772 79640722
Nosocomial infection 14.26 12.97 11 34883 2821 79706673
Drug eruption 14.25 12.97 47 34847 43888 79665606
Respiratory failure 14.19 12.97 131 34763 180780 79528714
Drug ineffective for unapproved indication 14.18 12.97 52 34842 51186 79658308
Blood phosphorus decreased 14.15 12.97 16 34878 6652 79702842
Corneal deposits 14.11 12.97 6 34888 492 79709002
Ejection fraction decreased 14.03 12.97 40 34854 34537 79674957
Lung infiltration 14.03 12.97 31 34863 22881 79686613
Fixed eruption 13.85 12.97 11 34883 2943 79706551
Haemolysis 13.69 12.97 22 34872 12790 79696704
Nephropathy 13.67 12.97 19 34875 9719 79699775
Sedation 13.64 12.97 3 34891 51892 79657602
Pseudomonas infection 13.62 12.97 29 34865 20874 79688620
Hyperpyrexia 13.58 12.97 15 34879 6077 79703417
VIIIth nerve injury 13.51 12.97 3 34891 25 79709469
Pseudomonas test positive 13.48 12.97 9 34885 1843 79707651
Auditory neuropathy spectrum disorder 13.41 12.97 3 34891 26 79709468
Malnutrition 13.28 12.97 30 34864 22472 79687022
Dermatitis bullous 13.27 12.97 23 34871 14222 79695272
Status epilepticus 13.26 12.97 32 34862 25009 79684485
Gingival swelling 13.24 12.97 13 34881 4596 79704898
Coagulation time prolonged 13.24 12.97 10 34884 2485 79707009
Retinal toxicity 13.11 12.97 8 34886 1403 79708091

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Foetal exposure during pregnancy 63.65 27.04 9 603 12832 76348
Drug ineffective 42.28 27.04 43 569 1009 88171
Blister 28.01 27.04 7 605 0 89180

Pharmacologic Action:

SourceCodeDescription
ATC D06AX07 DERMATOLOGICALS
ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
ANTIBIOTICS FOR TOPICAL USE
Other antibiotics for topical use
ATC J01GB03 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
AMINOGLYCOSIDE ANTIBACTERIALS
Other aminoglycosides
ATC S01AA11 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
ATC S02AA14 SENSORY ORGANS
OTOLOGICALS
ANTIINFECTIVES
Antiinfectives
ATC S03AA06 SENSORY ORGANS
OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
ANTIINFECTIVES
Antiinfectives
FDA CS M0000946 Aminoglycosides
FDA EPC N0000175477 Aminoglycoside Antibacterial
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011500 Protein Synthesis Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
Infection due to Pseudomonas aeruginosa indication 11218009
Folliculitis indication 13600006 DOID:4409
Infection of skin AND/OR subcutaneous tissue indication 19824006
Pneumonia due to Pseudomonas indication 41381004
Peritonitis indication 48661000
Pneumonia due to Escherichia coli indication 51530003
Bacterial pneumonia indication 53084003 DOID:874
Blepharoconjunctivitis indication 68659002 DOID:2456
Infection due to Escherichia coli indication 71057007
Bacterial infection due to Serratia indication 71120004
Paronychia indication 71906005 DOID:13117
Rhinoscleroma indication 72409005 DOID:11336
Septicemia due to Serratia indication 82091000
Cholangitis indication 82403002 DOID:9446
Dacryocystitis indication 85777005 DOID:9938
Bacterial meningitis indication 95883001 DOID:9470
Infection of bone indication 111253001
Furunculosis indication 112650006
Infectious disease of abdomen indication 128070006
Bacterial conjunctivitis indication 128350005 DOID:9700
Bacterial infection of skin indication 128936008
Infection due to Enterobacteriaceae indication 128945009
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Proteus pneumonia indication 195888009
Sepsis of the newborn indication 206376005
Neonatal pneumonia indication 233619008
Neonatal meningitis indication 276674008
Proteus septicemia indication 300986008
Meibomianitis indication 309779001
Infective blepharitis indication 312219000
Bacterial keratitis indication 314557000
Infectious disorder of joint indication 363162000
Sepsis due to Pseudomonas indication 448813005
Sepsis due to Gram negative bacteria indication 449082003
Skin and Skin Structure Proteus Infection indication
Synergy for Staphylococcus Aureus Pneumonia indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Enterobacter Pneumonia indication
Synergy for Klebsiella Meningitis indication
Burn Wound Infections indication
Complicated UTI with Pseudomonas Aeruginosa indication
Pseudomonas Aeruginosa Osteomyelitis indication
Synergy for Proteus Meningitis indication
Synergy for Group B Streptococcal Septicemia indication
Citrobacter Pneumonia indication
Synergy for Staphylococcal Endocarditis indication
Synergy for Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Synergy for Pseudomonas Aeruginosa Joint Infection indication
Pseudomonas Aeruginosa Joint Infection indication
Skin and Skin Structure Serratia Infection indication
Synergy for Pseudomonas Aeruginosa Osteomyelitis indication
Synergy for Neonatal Meningitis indication
Pseudomonas Aeruginosa Meningitis indication
Synergy for Staphylococcal Joint Infection indication
Citrobacter Septicemia indication
Pseudomonas Aeruginosa Biliary Tract Infection indication
Skin and Skin Structure Citrobacter Infection indication
Synergy for Pseudomonas Aeruginosa Pneumonia indication
Synergy for Bacterial Meningitis indication
Synergy for Staphylococcus Skin and Skin Structure Infection indication
Complicated Urinary Tract Infections indication
Synergy for Pseudomonas Aeruginosa Meningitis indication
Synergy for Staphylococcal Septicemia indication
Complicated Bacterial Peritonitis indication
Synergy for Staphylococcal Infections indication
Synergy for Pseudomonas Aeruginosa Septicemia indication
Synergy for Citrobacter Meningitis indication
Synergy for Serratia Meningitis indication
Synergy for Enterobacter Meningitis indication
Klebsiella Septicemia indication
Synergy for Escherichia Coli Meningitis indication
Necrotizing enterocolitis in fetus OR newborn off-label use 2707005
Pyrexia of unknown origin off-label use 7520000
Ecthyma gangrenosum off-label use 17732003
Enteric campylobacteriosis off-label use 18081009
Pseudotuberculosis off-label use 36753006
Plague off-label use 58750007 DOID:3482
Infection by Yersinia enterocolitica off-label use 80960004
Infection by Campylobacter fetus off-label use 111835002
Listeria Monocytogenes Septicemia off-label use
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis off-label use
Synergy for Prevention of Enterococcal Endocarditis off-label use
Prevention of Perioperative Infection off-label use
Synergy for Streptococcal Endocarditis off-label use
Synergy for Enterococcal Endocarditis off-label use
Synergy for Listeria Monocytogenes Septicemia off-label use
Synergy for Enterococcal Infections off-label use
Ocular hypertension contraindication 4210003 DOID:9282
Hypocalcemia contraindication 5291005
Herpes simplex keratitis contraindication 9389005
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Severe myopia contraindication 34187009
Tuberculosis of eye contraindication 49107007
Tinnitus contraindication 60862001
Diabetes mellitus contraindication 73211009 DOID:9351
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Eye infection contraindication 128351009
Bacterial infection of eye contraindication 128984004
Pregnancy, function contraindication 289908002
Viral eye infection contraindication 312132001
Vaccinia keratitis contraindication 397552005
Vertigo contraindication 399153001
Denuded skin contraindication 418242004
Infant Botulism contraindication
Disorder of the 8th Cranial Nerve contraindication
Gentamicin Toxicity contraindication




๐Ÿถ Veterinary Drug Use

SpeciesUseRelation
Cats Urinary tract infections Indication
Cats Respiratory tract infections Indication
Cats Skin and soft tissue infections Indication
Cats Supportive therapy for secondary bacterial infections associated with panleucopenia Indication
Cats Conjunctivitis Indication
Cattle Infectious bovine keratoconjunctivitis associated with Moraxella bovis Indication
Chickens Prevention of early mortality caused by Escherichia coli Indication
Chickens Prevention of early mortality caused by Salmonella typhimurium Indication
Chickens Prevention of early mortality caused by Pseudomonas aeruginosa Indication
Dogs External eye infections Indication
Dogs Acute and chronic otitis externa caused by bacteria Indication
Dogs Urinary tract infections Indication
Dogs Respiratory tract infections Indication
Dogs Skin and soft tissue infections Indication
Horses Uterus infections Indication
Horses Improving conception in mares with uterine infections Indication
Swine Dysentery associated with Brachyspira hyodysenteriae Indication
Swine PorcinEscherichia colibacillosis caused by Escherichia coli Indication
Turkeys Prevention of early mortality caused by Arizona paracolon infections Indication
Turkeys Reduction or elimination of Arizona hinshawii Indication
Turkeys Reduction or elimination of Salmonella st paul Indication
Turkeys Reduction or elimination of Mycoplasma meleagris Indication

๐Ÿถ Veterinary products

ProductApplicantIngredients
Gentocin Durafilm Intervet Inc. 2
Gentocin Solution Intervet Inc. 1
Gentocin Solution Intervet Inc. 1
Gentocin Otic Solution Intervet Inc. 2
Garacin Intervet Inc. 1
Garasol Solution Intervet Inc. 1
Gentocin Ophthalmic Ointment Intervet Inc. 1
Gentocin Ophthalmic Solution Intervet Inc. 1
Garasol Injection Intervet Inc. 1
Garacin Piglet Injection Intervet Inc. 1
Topagen Ointment Intervet Inc. 2
Gentocin (Garacin) Pig Pump Oral Solution Intervet Inc. 1
Gentocin Pink Eye Spray Intervet Inc. 1
Gentocin Topical Spray Intervet Inc. 2
Garacin Soluble Powder Intervet Inc. 1
Gentamicin Sulfate Inj. Sol. Cronus Pharma Specialities India Private Limited 1
Otomax Intervet Inc. 3
Mometamax Otic Suspension Intervet Inc. 3
Easotic Virbac AH Inc. 3
Gentamicin Sulfate Solution 100 mg/ml Cronus Pharma Specialities India Private Limited 1
Gentamicin Sulfate Solution, Legacy Sterile Solution Huvepharma EOOD 1
Gentaglyde Solution Zoetis Inc. 1
Gentamex 100 Bimeda Animal Health Limited 1
GentaMax 100 Elanco US Inc. 1
Genta-Ject, Gentamicin Sulfate Injection Huvepharma EOOD 1
Gentamicin Sulfate Pig Pump Oral Solution Huvepharma EOOD 1
VET BETA-GEN Med-Pharmex Inc. 2
GEN-GARD Huvepharma EOOD 1
Betagen Topical Spray Med-Pharmex Inc. 2
GENTORAL Med-Pharmex Inc. 1
Gentasol Med-Pharmex Inc. 1
Tri-Otic Ointment Med-Pharmex Inc. 3
Vetro-Gen Veterinary Ophthalmic Ointment Dechra Veterinary Products LLC 1
Vetro-Max Fougera Pharmaceuticals Inc. 3
GBC Ointment Cronus Pharma Specialities India Private Limited 3
GB Topical Spray Dechra Veterinary Products LLC 2
Gentamicin Piglet Injection Sparhawk Laboratories Inc. 1
Gentamicin Sulfate Solution Sparhawk Laboratories Inc. 1
Gentamicin Sulfate Topical Spray First Priority Inc. 2
Gentamicin Topical Spray Sparhawk Laboratories Inc. 2
GentaMed-P for Poultry Injection Bimeda Animal Health Limited 1
GentaMed Bimeda Animal Health Limited 1
Mometavet Med-Pharmex Inc. 3
Gentamicin Sulfate Ophthalmic Solution Akorn Animal Health Inc. 1

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dihydrofolate reductase Enzyme IC50 4.74 CHEMBL
Transient receptor potential cation channel subfamily V member 5 Ion channel INHIBITOR IC50 6 IUPHAR
Dihydrofolate reductase Enzyme IC50 4.60 CHEMBL
Transient receptor potential cation channel subfamily A member 1 Ion channel GATING INHIBITOR IC50 5.20 IUPHAR

External reference:

IDSource
4019765 VUID
N0000179542 NUI
D01063 KEGG_DRUG
4018210 VANDF
4019765 VANDF
C3854019 UMLSCUI
CHEBI:17833 CHEBI
CHEMBL3039597 ChEMBL_ID
CHEMBL463809 ChEMBL_ID
CHEMBL3039594 ChEMBL_ID
D005839 MESH_DESCRIPTOR_UI
DB00798 DRUGBANK_ID
2427 IUPHAR_LIGAND_ID
1617 INN_ID
T6Z9V48IKG UNII
3467 PUBCHEM_CID
1596450 RXNORM
228599 MMSL
4779 MMSL
d00014 MMSL
002778 NDDF
004898 NDDF
2249001 SNOMEDCT_US
387321007 SNOMEDCT_US
57752001 SNOMEDCT_US
1403-66-3 SECONDARY_CAS_RN

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PRED-G HUMAN PRESCRIPTION DRUG LABEL 2 0023-0066 OINTMENT 3 mg OPHTHALMIC NDA 17 sections
PRED-G HUMAN PRESCRIPTION DRUG LABEL 2 0023-0106 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 18 sections
Gentamicin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9128 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 16 sections
Gentamicin HUMAN PRESCRIPTION DRUG LABEL 1 0143-9129 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 16 sections
Gentamicin sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0168-0078 OINTMENT 1 mg TOPICAL ANDA 10 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0503 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0503 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0503 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0505 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0505 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0505 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0507 INJECTION, SOLUTION 60 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0507 INJECTION, SOLUTION 60 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0507 INJECTION, SOLUTION 60 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0509 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0509 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0509 INJECTION, SOLUTION 80 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0511 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0511 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate in Sodium Chloride HUMAN PRESCRIPTION DRUG LABEL 1 0338-0511 INJECTION, SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9865 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 12 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0404-9865 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 12 sections
Gentamicin HUMAN PRESCRIPTION DRUG LABEL 1 0404-9866 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 13 sections
Gentamicin HUMAN PRESCRIPTION DRUG LABEL 1 0404-9866 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 13 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1207 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 17 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1207 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 17 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0409-1207 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 17 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0682 OINTMENT 1 mg TOPICAL ANDA 9 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0682 OINTMENT 1 mg TOPICAL ANDA 9 sections
Gentamicin Sulfate HUMAN PRESCRIPTION DRUG LABEL 1 0713-0683 CREAM 1 mg TOPICAL ANDA 9 sections